US11813176B2 - Spinal fusion device - Google Patents
Spinal fusion device Download PDFInfo
- Publication number
- US11813176B2 US11813176B2 US17/518,095 US202117518095A US11813176B2 US 11813176 B2 US11813176 B2 US 11813176B2 US 202117518095 A US202117518095 A US 202117518095A US 11813176 B2 US11813176 B2 US 11813176B2
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- fusion device
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- 230000004927 fusion Effects 0.000 title claims abstract description 123
- 230000007704 transition Effects 0.000 claims abstract description 7
- 239000000463 material Substances 0.000 claims description 31
- 238000003780 insertion Methods 0.000 claims description 13
- 230000037431 insertion Effects 0.000 claims description 13
- 238000000034 method Methods 0.000 claims description 12
- 239000007943 implant Substances 0.000 claims description 3
- 230000008878 coupling Effects 0.000 claims 1
- 238000010168 coupling process Methods 0.000 claims 1
- 238000005859 coupling reaction Methods 0.000 claims 1
- 210000000988 bone and bone Anatomy 0.000 description 6
- 230000008569 process Effects 0.000 description 5
- 208000020307 Spinal disease Diseases 0.000 description 4
- 238000002347 injection Methods 0.000 description 4
- 239000007924 injection Substances 0.000 description 4
- 230000008468 bone growth Effects 0.000 description 3
- 230000007246 mechanism Effects 0.000 description 3
- 238000007499 fusion processing Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000007850 degeneration Effects 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 230000000921 morphogenic effect Effects 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 239000004557 technical material Substances 0.000 description 1
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- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2/4637—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for connecting or disconnecting two parts of a prosthesis
- A61F2002/4638—Tools for performing screwing, e.g. nut or screwdrivers, or particular adaptations therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
Definitions
- a degenerated spinal disc may be treated by installing a fusion device into the intervertebral space and providing bone graft material through the installed fusion device to fuse the upper and lower vertebral bodies. While installing the fusion device, the fusion device may be susceptible to external forces applied thereto, which may result in structural failure of the fusion device. Facilitation of providing the bone graft material may be desirable to improve bone growth in fusing the upper and lower vertebral bodies.
- Embodiments of the present application relate to a fusion device and a process of using the fusion device to treat spinal disorders.
- a fusion device in an embodiment, includes an actuator including a shaft, a receiver disposed posterior to the actuator and configured to be coupled to the shaft of the actuator, and a first plate and a second plate each slidably coupled to the actuator.
- the first and second plates are configured to move away from each other when the fusion device transitions from a first state to a second state.
- an implant in an embodiment, includes an actuator including a hollow shaft, a receiver disposed posterior to the actuator and configured to be coupled to the hollow shaft of the actuator, a connector rotatably coupled to the receiver, and a first plate and a second plate each slidably coupled to the actuator and the connector.
- the first and second plates are configured to move away from each other when the fusion device transitions from a first state to a second state.
- the shaft has a through hole for delivering material therethrough, and the first state is a non-expanded state and the second state is an expanded state.
- a method of using a fusion device includes inserting a fusion device in a first state into a treatment region, transitioning the fusion device from the first state to a second state by inserting the hollow shaft of the actuator into the receiver, and injecting material through the channel of the fusion device to make the injected material flow out from the opening of the actuator.
- FIG. 1 and FIG. 2 illustrate a fusion device in a first state (e.g., a non-expanded state) and a second state (e.g., an expanded state), respectively, according to an embodiment of the present disclosure
- FIGS. 3 A, 3 B, and 3 C illustrate a top view, a cross-sectional view, and a rear view of the fusion device of FIG. 1 in the non-expanded state, according to an embodiment of the present disclosure.
- FIGS. 4 A, 4 B, and 4 C illustrate a top view, a cross-sectional view, and a rear view of the fusion device of FIG. 2 in the expanded state, according to an embodiment of the present disclosure.
- FIG. 5 illustrates an exploded view of the fusion device of FIGS. 1 and 2 according to an embodiment of the present disclosure.
- FIG. 6 illustrates a top view of an actuator of the fusion device of FIGS. 1 and 2 according to an embodiment of the present disclosure.
- FIG. 7 illustrates a fusion device locked in an expanded state using a set fastener according to an embodiment of the present disclosure.
- FIGS. 8 A, 8 B, and 8 C illustrate a perspective view, a side view, and a rear view of the set fastener of FIG. 7 according to an embodiment of the present disclosure.
- FIG. 9 illustrates an exploded view of a fusion device according to an embodiment of the present disclosure.
- FIG. 10 illustrates an exploded view of a fusion device according to an embodiment of the present disclosure.
- FIG. 11 is a flowchart illustrating a process of using a fusion device to treat spinal disorders according to an embodiment.
- FIG. 12 illustrates an insertion tool used to insert a fusion device according to an embodiment of the present disclosure.
- Embodiments of the present application relate to a fusion device and a process of using the fusion device to treat spinal disorders.
- a fusion device (may also be referred to as, “implant” or “spinal device”) includes an actuator including a shaft, a receiver disposed posterior to the actuator and configured to be coupled to the shaft of the actuator, a connector rotatably coupled to the receiver, and a first plate and a second plate each slidably coupled to the actuator and the connector.
- the first and second plates may move away from each other when the fusion device transitions from a first state (e.g., a non-expanded state) to a second state (e.g., an expanded state).
- the receiver Since the receiver is disposed posterior to the actuator and have a threaded inner surface to which an outer threaded surface of the hollow shaft is coupled, the receiver may have a relatively long longitudinal length to ensure structural reliability of the fusing device.
- the shaft may be hollow depending on implementation.
- the actuator further includes an anterior portion slidably coupled to the first plate and the second plate, a posterior portion, and an opening disposed between the anterior portion and the posterior portion.
- the opening may be sufficiently great to facilitate injection of material for improving bone growth (or bone fusion) in a fusion process, and sufficiently small to ensure the structural reliability of the fusing device.
- the receiver is configured to receive a set fastener to substantially fix a position of a posterior end of the hollow shaft of the actuator, thereby locking the fusion device at a desired height. Since the set fastener and the receiver together may provide a robust locking mechanism for the hollow shaft, the position of the posterior end of the hollow shaft may be substantially fixed to maintain an expanded height of the actuator at a target value while ensuring the structural reliability of the fusion device.
- a method of using a fusion device includes inserting the fusion device in a non-expanded state into a treatment region, transitioning the fusion device from the non-expanded state to an expanded state by inserting a hollow shaft of the actuator into the receiver, and injecting material through a channel of the fusion device to make the injected material flow out from an opening of the actuator.
- the injected material may be bone graft material, bone morphogenic protein, or other materials, or a combination thereof, that may be used to facilitate the fusing of the fusion device to the bone (hereinafter, referred to as “fusing material.”)
- FIG. 1 and FIG. 2 illustrate a fusion device 10 in a first state (e.g., a non-expanded state) and a second state (e.g., an expanded state), respectively, according to an embodiment of the present disclosure.
- FIGS. 3 A, 3 B, and 3 C illustrate a top view, a cross-sectional view, and a rear view of the fusion device 10 in the non-expanded state, respectively, according to an embodiment of the present disclosure.
- the cross-sectional view shown in FIG. 3 B of the fusion device 10 may be obtained by cutting the fusion device 10 along a line A-A′ shown in FIG. 3 A .
- FIG. 4 A, 4 B, and 4 C illustrate a top view, a cross-sectional view, and a rear view of the fusion device 10 in the expanded state, respectively, according to an embodiment of the present disclosure.
- the cross-sectional view shown in FIG. 4 B of the fusion device 10 may be obtained by cutting the fusion device 10 along a line B-B′ shown in FIG. 4 A .
- FIG. 5 illustrates an exploded view of the fusion device 10 according to an embodiment of the present disclosure.
- FIG. 6 illustrates a top view of an actuator 6 included in the fusion device 10 according to an embodiment of the present disclosure.
- the fusion device 10 includes a first plate 2 (e.g., an upper plate), a second plate (e.g., a lower plate) 4 , an actuator 6 , a connector 12 , and a receiver 14 .
- a set fastener (or set screw) 52 may be inserted into the receiver 14 to lock the fusion device 10 at a given expanded state.
- the actuator 6 may include an anterior portion 34 , first and second side portions 36 a and 36 b , and a posterior portion 46 .
- the anterior portion 34 of the actuator 6 may include a pair of upper grooves 62 slidably coupled to a pair of first grooves 18 of the first plate 2 , and a pair of lower grooves (not shown) slidably coupled to a pair of first grooves 58 of the second plate 4 .
- the anterior portion 34 may further include a through hole 48 through which a guide wire may be inserted. As explained below, the through hole may also be used to inject fusing material therethrough.
- the first and side portions 36 a and 36 b of the actuator 6 may couple the anterior portion 34 and the posterior portion 46 , such that a posterior end of the anterior portion 34 , inner side surfaces of the first and second side portions 36 a and 36 b , and an anterior end of the posterior portion 46 define an opening 70 .
- Each of the first and second side portions 36 a and 36 b may have an upper ramp surface 44 and a lower ramp surface 82 that are slidably coupled to a ramp surface 42 of the first plate 2 and a ramp surface 84 of the second plate 4 , respectively.
- the posterior portion 46 of the actuator 6 may include a first wedge (e.g., an upper wedge) 86 and a second wedge (e.g., a lower wedge) 88 that are slidably coupled to the first and second plates 2 and 4 , respectively.
- the upper wedge 86 of the posterior portion 46 may include a pair of upper grooves 48 that are slidably coupled to a pair of grooves 20 of the first plate 2 .
- the posterior portion 46 may further include a hollow shaft 32 that extends in a longitudinal direction along a centerline CL of the fusion device 10 .
- the hollow shaft 32 has a threaded outer surface 90 to be coupled to an inner surface 74 of the receiver 14 .
- the outer surface 90 of the hollow shaft 32 may have a male thread and the inner surface 74 of the receiver 14 may have a female thread.
- embodiments of the present disclosure are not limited thereto.
- the receiver 14 may include a first portion 38 .
- the first portion 38 of the receiver 14 may have the inner surface 74 coupled to the outer surface 90 of the hollow shaft 32 and an outer surface 76 rotatably coupled to a through hole 30 of the connector 12 . Since the receiver 14 may be disposed posterior to the actuator 6 and have the threaded inner surface 74 to which the outer threaded surface 90 of the hollow shaft 32 is coupled, the receiver 14 may have a relatively long length in the longitudinal direction. For example, referring to FIG. 3 B illustrating the fusion device 10 in the non-expanded state, a longitudinal length L R of the receiver 14 along the centerline CL may be in a range from 25% to 45% of a longitudinal length L FD of the fusion device 10 along the centerline CL.
- the hollow shaft 32 of the actuator 6 may not be inserted into the receiver 14 with a sufficient depth to ensure the structural reliability of the fusion device 10 .
- a size of the opening 70 of the actuator 6 may be reduced to such a degree that the size is not sufficiently large to facilitate injection of fusing material, as will be described below in more detail.
- the longitudinal length L R of the receiver 14 along the centerline CL is at least 30% of the longitudinal length L FD of the fusion device 10 along the centerline CL.
- the longitudinal length L R of the receiver 14 along the centerline CL is at least 35% of the longitudinal length L FD of the fusion device 10 along the centerline CL. In yet another embodiment, the longitudinal length L R of the receiver 14 along the centerline CL is at least 40% of the longitudinal length L FD of the fusion device 10 along the centerline CL.
- the receiver 14 may further include a second portion 40 disposed posterior to the first portion 38 .
- the second portion 40 of the receiver 14 may have an inner surface 78 with a cross-sectional shape matching that of an end of a driving tool for rotating the receiver 14 .
- the second portion 40 may have a polygon shape with a size (e.g., a distance between opposite sides of the polygon shape) greater than a size (e.g., a major diameter of the internal thread) of the inner surface 74 of the first portion 38 .
- the insertion driver may be inserted into the second portion 40 of the receiver 14 to rotate the receiver 14 in a given rotational direction, thereby causing the actuator 6 to move along the centerline CL in a posterior direction to increase a length of a portion of the hollow shaft 32 inserted into the first portion 38 of the receiver 14 .
- the actuator 6 drives the first and second plates 2 and 4 away from the centerline CL of the fusion device 10 , leading to the expanded state of the fusion device 10 shown in FIGS. 2 and 4 A- 4 C .
- the length of the inserted portion of the hollow shaft 32 may be adjusted until an expanded height (e.g., a height H EXP between a bottom surface of the second plate 4 and an upper surface of the first plate 2 in FIG. 4 B ) of the actuator 6 reaches a desired height.
- an expanded height e.g., a height H EXP between a bottom surface of the second plate 4 and an upper surface of the first plate 2 in FIG. 4 B
- fusing material may be provided to the fusion device 10 .
- an injecting device (not shown) may be inserted into the receiver 14 to inject the fusing material through the through hole 92 of the hollow shaft 32 , and the injected fusing material may flow out from the opening 70 of the actuator 6 .
- the opening 70 of the actuator 6 may be sufficiently great to facilitate the injection of the fusing material, thereby improving the bone growth in the fusion process.
- the opening 70 of the actuator 6 may be sufficiently small to ensure the structural reliability of the actuator 60 . For example, referring to FIG.
- the opening 70 when the opening 70 may have a first length L 1 in a longitudinal direction of the actuator 6 and a second length L 2 in a direction perpendicular to the longitudinal direction, the first length L 1 of the opening 70 may be in a range from 15% to 30% of a total length L 3 of the actuator 6 in the longitudinal direction, and the second length L 2 of the opening 70 may be in a range from 50% to 70% of a total length L 4 of the actuator 6 in the direction perpendicular to the longitudinal direction.
- the first length L 1 of the opening 70 is at least 20% (e.g., about 22%) of a total length L 3 of the actuator 6 in the longitudinal direction, and the second length L 2 of the opening 70 is at least 58% (e.g., about 60%) of a total length L 4 of the actuator 6 in the direction perpendicular to the longitudinal direction.
- the first length L 1 of the opening 70 is at least 25% of a total length L 3 of the actuator 6 in the longitudinal direction
- the second length L 2 of the opening 70 is at least 63% of a total length L 4 of the actuator 6 in the direction perpendicular to the longitudinal direction.
- a set fastener (e.g., the set fastener 52 in FIG. 7 ) may be inserted into the receiver 14 .
- the set fastener 52 may be inserted until an anterior end of the set fastener 52 contacts a posterior end of the hollow shaft 32 . Since the set fastener 52 and the receiver 14 together may provide a robust locking mechanism for the hollow shaft 32 , the position of the posterior end of the hollow shaft 32 may be substantially fixed to maintain the expanded height of the actuator 6 at the desired height while ensuring the structural reliability of the fusion device 10 .
- the set fastener 52 may have a threaded outer surface to be inserted into the receiver 14 .
- the set fastener 52 may have a threaded outer surface 75 to be coupled to the inner surface 74 of the receiver 14 .
- FIG. 9 illustrates an exploded view of a fusion device 100 according to an embodiment of the present disclosure.
- the fusion device 100 includes a first plate 102 , a second plate 104 , an actuator 106 , a connector 112 , and a receiver 114 , and one or more pins 111 . Descriptions on structural and functional features of the fusion device 100 similar to those of the fusion device 10 in FIGS. 1 to 6 may be omitted for the interest of brevity.
- the fusion device 100 in FIG. 9 differs from the fusion device 10 in FIGS. 1 to 6 in that the first plate 102 and the second plate 104 of the fusion device 100 have different structures from each other, whereas the first plate 2 and second plate 4 of the fusion device 10 have substantially the same structure.
- the first plate 102 of the fusion device 100 has a side portion 113 slidably coupled to a first recess 117 of the second plate 104 .
- the fusion device 100 in FIG. 9 also differs from the fusion device 10 in FIGS.
- the connector 112 of the fusion device 100 includes a side portion 115 slidably coupled to the side portion 113 of the first plate 102 and a second recess 119 of the second plate 104 .
- the fusion device 100 in FIG. 9 differs from the fusion device 10 in FIGS. 1 to 6 in that the pins 111 are received by the connector 112 to engage a neck 121 of the receiver 114 , thereby retaining the receiver 114 within the connector 112 while allowing the receiver 114 to rotate for expanding the fusion device 100 .
- FIG. 10 illustrates an exploded view of a fusion device 200 according to an embodiment of the present disclosure.
- the fusion device 200 includes a first plate 202 , a second plate 204 , an actuator 206 , a connector 212 , and a receiver 214 , and one or more pins 211 . Descriptions on structural and functional features of the fusion device 200 similar to those of the fusion device 10 in FIGS. 1 to 6 may be omitted for the interest of brevity.
- the fusion device 200 in FIG. 10 differs from the fusion device 10 in FIGS. 1 to 6 in that the actuator 206 of the fusion device 200 includes a side upper portion 237 and a side lower portion 231 each extending in an oblique direction with respect to a longitudinal direction of the actuator 206 , and that the first plate 202 and the second plate 204 include recesses 233 and 235 slidably coupled to the side upper and lower portions 237 and 231 , respectively.
- the fusion device 200 in FIG. 10 differs from the fusion device 10 in FIGS. 1 to 6 in that the pins 211 functions to engage a neck 221 of the receiver 214 , thereby retaining the receiver 214 within the connector 212 while allowing the receiver 214 to rotate for expanding the fusion device 200 .
- FIG. 11 is a flowchart illustrating a process of using a fusion device (e.g., the fusion device 10 in FIGS. 1 to 6 ) to treat spinal disorders according to an embodiment.
- a fusion device e.g., the fusion device 10 in FIGS. 1 to 6
- such treatment may be a Posterior Lumbar Interbody Fusion (PLIF) surgery.
- PLIF Posterior Lumbar Interbody Fusion
- the fusion device in a first state may be attached to an insertion tool.
- an insertion tool may include a pair of prongs to be inserted into corresponding holes (e.g., side holes 79 of the connector 12 in FIG. 5 ) of the fusion device for attaching the fusion device to the insertion tool.
- FIG. 12 illustrates an insertion tool 77 according to an embodiment of the present disclosure.
- the insertion tool 77 may include a sleeve 85 and an inserter body having a pair of prongs 83 and passing through the sleeve 85 .
- the insertion tool 77 may be coupled to an injecting device 87 used to inject fusing material as will be described below in more detail.
- the fusion device in the first state may be inserted into a treatment region (e.g., a damaged intervertebral disc space) using the insertion tool.
- a portion of the insertion tool may be removed and the remaining portion of the insertion tool may be coupled with a structure suitable for applying an external force thereon.
- the structure may have a posterior end having a relatively large cross-sectional area onto which a hammer strikes to exert the external force.
- the fusion device may transition from the first state to a second state (e.g., the expanded state).
- a portion (e.g., the hollow shaft 32 in FIGS. 4 B and 5 ) of an actuator e.g., the actuator 6 in FIGS. 4 B and 5
- a height e.g., the expanded height H EXP in FIG. 4 B
- a driving tool may be inserted into a receiver (e.g., the receiver 14 in FIGS.
- first and second plates e.g., the upper and lower plates 2 and 4 in FIGS. 1 to 6 .
- material may be provided to the fusion device.
- an injecting device e.g., the injecting device 87 in FIG. 12
- a channel e.g., the through hole 92 of the hollow shaft 32 in FIG. 4 B
- Such a channel may be used to deliver the fusing material therethrough and be exposed to an opening (e.g., the opening 70 of the actuator 6 in FIG. 6 ), and thus the injected material through the channel may flow out from the opening.
- a set fastener (e.g., the set fastener 52 in FIG. 7 ) may be inserted into the receiver.
- the set fastener may have a threaded outer surface (e.g., the threaded outer surface 75 in FIGS. 8 B ) to be coupled to a threaded inner surface (e.g., the inner surface 74 in FIG. 7 ) of the receiver, leading to a robust locking mechanism for a portion (e.g., the hollow shaft 32 of the actuator 6 inserted into the receiver 14 in FIG. 4 B ) of the actuator inserted into the receiver.
- the fusion device may be locked in a desired height without the set fastener, in which case step S 1150 may be performed optionally.
Abstract
Description
Claims (16)
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US17/518,095 US11813176B2 (en) | 2020-11-04 | 2021-11-03 | Spinal fusion device |
KR1020220115764A KR20230065149A (en) | 2021-11-03 | 2022-09-14 | Spinal fusion device |
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US202063109663P | 2020-11-04 | 2020-11-04 | |
US17/518,095 US11813176B2 (en) | 2020-11-04 | 2021-11-03 | Spinal fusion device |
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